Covid-19 Living Data

Trial NCT05293548
Publication Al Kaabi N, Signal Transduct Ther, 2023
Dates: 2022-05-25 to 2022-05-30
Funding: Private (Lanzhou Institute of Biological Products Co., Ltd (LIBP) of Sinopharm, and Beijing Institute of Biological Products Co., Ltd (BIBP) of Sinopharm. X.J.G., X.Y.M., H.W., and J. Zhang are employees of the funders.)
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / United Arab Emirates Follow-up duration (months): 1
	0.5 mL NVSI-06-09 (n=260) 0.5 mL BBIBP-CorV (n=256)
Inclusion criteria	Healthy men and nonpregnant women aged 18 years or above had previously vaccinated with two or three doses of BBIBP-CorV at least 6 months prior to enrollment signed an informed consent form healthy status of each volunteer was assessed by inquiry and physical examination.
Exclusion criteria	Previously received any other COVID-19 vaccine instead of the BBIBP-CorV Individuals whose axillary temperature ≥37.3 °C (or forehead temperature ≥37.8 °C) allergic to any components of the vaccine history of thrombocytopenia or other coagulation disorders immunological impairment or immunocompromise receipt of any blood products or immunoglobulin therapy within 3 months prior to enrollment serious chronic disease receipt of any other inactivated vaccines in the past 14 days, or any live attenuated vaccines post one month receipt of any investigational drugs within 6 months prior to enrollment and other vaccination-related contraindications considered by the investigator.
Interventions
	Intervention 1 IM 20 mcg dose of NVSI-06-09, at least 6 months after BBIBP-CorV primary schedule
	Control 1 IM 6.5U dose of BBIBP-CorV, at least 6 months after BBIBP-CorV primary schedule
Participants
	Randomized 516 participants
	Characteristics of participants Type of participants: Healthy adults N=516 488 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 19-62
	Description of participants Healthy adults previously vaccinated with two or three doses of BBIBP-CorV at least 6 months prior to enrollment at a single center in United Arab Emirates
Primary outcome
	In the register 1) GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age [ Time Frame: 14 days after sequential immunization of one booster dose ] 2) The 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age [ Time Frame: 14 days after a single dose of the booster vaccine ] 3) The incidence rate of any adverse reactions/events [ Time Frame: within 30 minutes after vaccination ] 4) The incidence severity of any adverse reactions/events [ Time Frame: within 30 minutes after vaccination ] 5) The incidence rate of solicited adverse reactions/events [ Time Frame: within 0-7 days after vaccination ] 6) The incidence severity of solicited adverse reactions/events [ Time Frame: within 0-7 days after vaccination ] 7) The incidence rate of solicited adverse reactions/events [ Time Frame: within 8-30 days after vaccination ] 8) The incidence severity of solicited adverse reactions/events [ Time Frame: within 8-30 days after immunization ] 9) The incidence of SAE observed [ Time Frame: up to 12 months after full course of immunization ] 10) The incidence of AESI observed [ Time Frame: up to 12 months after full course of immunization ]
	In the report The immunogenicity and safety of the booster vaccination of NVSI-06-09 against SARS-CoV-2 Omicron variant, in comparison with the boost of BBIBP-CorV, on day 14 after the vaccination. The immunogenicity was evaluated by the geometric mean titers (GMTs) of anti-Omicron neutralizing antibodies (nAbs), and the four-fold rise rate of the neutralizing GMTs from baseline. Anti-Omicron nAb titers were measured by live-virus microneutralization assays. The safety was assessed by occurrence and severity of adverse reactions.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes, The clinical trial is still ongoing, and the data will be available when the trial is complete upon request to the corresponding author (Q.M.L.). Data accessibility: After study proposals are approved, data can be shared through secure online platforms. Corresponding author: Qi Ming Li:liqiming189@163.com
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to all available versions of the published/pre-print article, the study registry, protocol and supplement were used in data extraction and risk of bias assessment. The article presented interim analyses for a study with ongoing follow-up. There were no important differences between protocol/registry and published report in population, procedures, interventions or outcomes. The target sample size (n=516) specified in the registry was achieved (n=516).